PHR1059

Supelco

Omeprazole

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
Losec, 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, Antra
Empirical Formula (Hill Notation):
C17H19N3O3S
CAS Number:
Molecular Weight:
345.42
MDL number:
PubChem Substance ID:
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

form

neat

CofA

current certificate can be downloaded

application(s)

HPLC: suitable
gas chromatography (GC): suitable

Featured Industry

Forensics and Toxicology
Pharmaceutical (small molecule)

format

neat

pharmacopeia traceability

traceable to BP 765
traceable to PhEur O0150000
traceable to USP 1478505

SMILES string

COc1ccc2[nH]c(nc2c1)S(=O)Cc3ncc(C)c(OC)c3C

InChI

1S/C17H19N3O3S/c1-10-8-18-15(11(2)16(10)23-4)9-24(21)17-19-13-6-5-12(22-3)7-14(13)20-17/h5-8H,9H2,1-4H3,(H,19,20)

InChI key

SUBDBMMJDZJVOS-UHFFFAOYSA-N

Gene Information

human ... ATP4A(495), ATP4B(496)

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General description

Omeprazole is a benzimidazole drug, which exhibits antisecretory and antiulcer properties. It is widely used in the treatment of duodenal, gastric ulcers, reflux oesophagitis and against other acid-related diseases.
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.
Omeprazole may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations using spectrophotometric technique and high-performance liquid chromatography technique.
Omeprazole may be used as a reference standard in the determination of omeprazole in pharmaceutical formulations using high performance thin layer chromatography (HPTLC).

Analysis Note

These secondary standards offer multi-traceability to the USP, EP (PhEur) and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAC0716 in the slot below. This is an example certificate only and may not be the lot that you receive.

RIDADR

NONH for all modes of transport

WGK Germany

WGK 2

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis
Certificate of Origin
A validated HPTLC method for determination of ondansetron in combination with omeprazole or rabeprazole in solid dosage form
Raval.B.P, et al.
Indian Journal of Pharmaceutical Sciences, 70(3), 386-386 (2008)
Extractive spectrophotometric determination of omeprazole in pharmaceutical preparations
Bhandage A, et al.
Tropical Journal of Pharmaceutical Research, 8(5), 1133-1142 (2009)
Spectrophotometric determination of omeprazole, lansoprazole and pantoprazole in pharmaceutical formulations
Wahbi AAM, et al.
Journal of Pharmaceutical and Biomedical Analysis, 30(4), 1133-1142 (2002)
A validated normal phase HPLC method for simultaneous determination of drotaverine hydrochloride and omeprazole in pharmaceutical formulation
Topagi SK, et al.
Asian Journal of Pharmaceutical and Clinical Research, 3(1), 20-24 (2010)
Kazuhiro Shiizaki et al.
Molecular pharmacology, 85(2), 279-289 (2013-11-23)
Omeprazole (OME) induces the expression of genes encoding drug-metabolizing enzymes, such as CYP1A1, via activation of the aryl hydrocarbon receptor (AhR) both in vivo and in vitro. However, the precise mechanism of OME-mediated AhR activation is still under investigation. While...

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